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FDA Issues Alert for Glucose Monitoring System

The FDA has issued an FDA Early Alert. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available. 

Affected Product:
The FDA is aware that Abbott Diabetes Care has issued a letter to distributors, health care providers, and affected customers recommending certain glucose monitor sensors be removed from where they are used or sold:
 
  • FreeStyle Libre 3 Sensor
    • Model Numbers: 72081-01, 72080-01
    • Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
  • FreeStyle Libre 3 Plus Sensor
    • Model Numbers: 78768-01, 78769-01
    • Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
Click Full list of affected lots

The full alert can be accessed here: Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care | FDA
  
Staff Contact: mcarland@mehca.org
 

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